Randomization

What is randomization?

Randomization is a process that assigns participants/subjects by chance (rather than by choice) into specific groups, typically for clinical research and clinical trials.

The randomization module in REDCap will help you implement a defined randomization model within your project, allowing you to randomize your subjects (i.e. records in your project). In this module, you first define the randomization model with various parameters. Based on the defined parameters, the module creates a template allocation table, which you can use to structure the randomization table you will import. The module also monitors the overall allocation progress and assignment of randomized subjects.

 

REDCap’s Randomization Module

Enabling Randomization

Enabling the randomization module requires the Project Design and Setup user privilege.

Project Setup > Enable optional modules and customizations > Randomization module

Once the module is enabled, a new section will be added to the Project Setup page.

 

Randomization User Privileges

Once the module is enabled, the Randomization privileges appear when assigning user privileges.
Existing users will need to be given rights to use the module.


Setting up Randomization

Setting up the randomization module requires the Randomization: Setup user privilege.

Once your randomization model is defined, template allocation tables are available. The template will give an idea of what your allocation table should look like to be understood by REDCap.

The allocation table is used for testing (development status) must be different from the one used in production.

It is recommended that only people with experience in randomization set up the Randomization module. Contact us at cru@ucalgary.ca if you would like support in setting up randomization.

 

Allocation Dashboard

Viewing the dashboard requires the Randomization: Dashboard user privilege.

The dashboard gives an overview of the randomization assignments thus far. It displays how many of the assignments are used and how many are unused.

 

Randomizing a Record to a Group

Randomizing a record to a group requires the Randomization: Randomize user privilege.

If stratification is used, someone with 'Randomize' privileges can view and modify any existing data already collected for the randomization strata fields, even if they do not specifically have form-level rights to view the form on which a strata field exists.

 

A user with the ‘Randomize’ privilege will have the option to perform randomization. Once a record is randomized to a group, its allocation (and the data in the strata fields, if any) cannot be changed.

 

 

 

 

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